BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMI250

    MDR report key: 18167242 · Received November 19, 2023

    Report

    Report Number
    3006404071-2023-00002
    Event Type
    Injury
    Date Received
    November 19, 2023
    Date of Event
    January 27, 2020
    Report Date
    November 19, 2023
    Manufacturer
    SPINESMITH HOLDINGS,LLC
    Product Code
    DWG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERMI250 WAS NOT EVALUATED BY SPINESMITH HOLDINGS,LLC IN (B)(6) 2020, AS THE COMPLAINT WAS DEEMED A NON ADVERSE EVENT AND NOT REPORTED. ASSUMPTION WAS THAT THE USER WAS RE-USING THE GROUNDING PAD, HOWEVER THERE IS NOT ENOUGH INFORMATION OBTAINED TO VERIFY THAT. SPINESMITH IS ATTEMPTING TO MAKE CONTACT FOR MORE INFORMATION ON THE DEVICE AND WHAT PROCEDURES ARE BEING PERFORMED.

    Description of Event or Problem · 0

    ACCOUNT NOTIFIED VIA EMAIL ON 02/13/2020, THAT ONE OF THEIR PATIENTS HAD A PROBLEM WITH THE THERMI250 SYSTEM. ON (B)(6) 2020 THE PATIENT WAS BURNED DURING A THERMISMOOTH TREATMENT. GROUNDING PAD FIT AND CABLES WERE OK. ACCOUNT IS WANTING TO KNOW IS IT POSSIBLE TO GET A NEW GROUNDING PAD FOR THIS SYSTEM. NO ADDITIONAL DETAILS WERE OBTAINED, HOWEVER THE REQUEST FOR AN ADDITIONAL GROUNDING PAD (SINGLE) POINTS TO THE POSSIBILITY THAT THE PAD WAS REUSED. GROUNDING PADS ARE SINGLE USE. THIS IS JUST AN ASSUMPTION AS THERE WAS NO ADDITIONAL DETAILS OBTAINED. ADDITIONAL FOLLOW UP VIA EMAIL OCCURED ON 01/07/2021, 06/10/2021, 07/13/2021, BY NEW SPINESMITH QUALITY MANAGEMENT. ATTEMPTS WERE MADE TO THE ACCOUNT IN ORDER TO REACH A ACCOUNT CONTACT. ON (B)(6) 2021 CUSTOMER RESPONDED THAT THE CASE CAN BE CLOSED WITH NO FURTHER COMMENTS. CASE WAS CLOSED ON 07/14/2021. DURING 2023 FDA AUDIT, INSPECTOR INDICATED THAT THE COMPLAINT REQUIRED RE-ASSESSMENT FOR ADVERSE EVENT REPORTING. CASE WAS RE-OPENED ON (B)(6) 2023. FOLLOW UP WAS ATTEMPTED ON 08/08/2023 AND 08/10/23 VIA PHONE CALL. VOICEMAIL WAS LEFT EACH TIME. FOLLOW UP EMAIL SENT 08/18/23. RESPONSE RECEIVED ON 08/22/23 INDICATING THAT THE CONTACT WAS NO LONGER WITH THE OFFICE. RESPONDER DID MENTION THAT THEY BUY GROUNDING PADS AND PERFORM THE THERMIVA PROCEDURE AND THEIR CUSTOMERS ARE VERY SATISFIED. CUSTOMER DID NOT MENTION THERMISMOOTH PROCEDURES. SPINESMITH QUALITY MANAGER AWAITING RESPONSE FROM REQUEST FOR MORE INFORMATION ON THE STATUS OF THE THERMISMOOTH PROCEDURE EMAIL SENT ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925375 THERMI250 THERMI250 RF GENERATOR DWG SPINESMITH HOLDINGS,LLC THERMI250

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other #2130AC GROUNDING PAD.